APPLIED MEDICAL RESOURCES CFR03, 5X100 KII OPT ADVFIX 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY
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Model Number CFR03 |
Device Problem
Device Contaminated During Manufacture or Shipping (2969)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/21/2023 |
Event Type
malfunction
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Manufacturer Narrative
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This report is a follow-up report to medwatch (b)(4).The event device is anticipated to return.A follow-up report will be provided upon completion of the investigation.
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Event Description
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Name of procedure being performed: laparoscopic, repair of anterior abdominal hernia (epigastric, incisional, ventral, umbilical, spigelian), laparoscopic, intal, inc implntn of mesh when perf, tot len of def; 3 cm incarc or strang.Detailed description of event: complaint created based off medwatch report.Uf/importer report (b)(4), hair found on the trocar during sterile field setup.Product is available for return.Patient status: (no patient involvement).Type of intervention: the defect was identified prior to the start of the case, and the item was removed.
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Manufacturer Narrative
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The event unit was returned to applied medical for evaluation.Visual inspection confirmed the presence of hair.Based on the condition of the returned unit and the description of the event, it is likely that the hair originated from an operator and was packaged with the product during the manufacturing process.This report is to follow-up medwatch #(b)(4).
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Event Description
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Name of procedure being performed: laparoscopic, repair of anterior abdominal hernia (epigastric, incisional, ventral, umbilical, spigelian), laparoscopic, intal, inc implntn of mesh when perf, tot len of def; < 3 cm; incarc or strang detailed description of event: complaint created based off medwatch report.Uf/importer report # (b)(4).Hair found on the trocar during sterile field setup.Product is available for return.Patient stauts: ni (no patient involvement).Type of intervention: the defect was identified prior to the start of the case and the item was removed.
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